Sr. Clinical Research Associate
4 months ago
The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager or Clinical Research Director, the person ensures compliance of study conduct with ICH/Good Clinical Practice and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as Subject Matter Expert for monitoring processes and systems.
**Qualifications, Skills & Experience**:
- Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
- Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines. - Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Demonstrated ability to mentor/lead.
- Hands on knowledge of Good Documentation Practices.
- Proven Skills in Site Management including independent management of site performance and patient recruitment.
- Demonstrated high level of monitoring skill with independent professional judgment.
- Ability to understand and analyze data/metrics and act appropriately, also in a virtual environment.
- Experience with conducting site motivational visit designed to boost site enrollment.
- Capable of managing complex issues, works in a solution-oriented manner. - Performs root cause analysis and implements preventative and corrective action.
- Capable of mentoring junior Clinical Research Associates on process/study requirements and is able to perform co-monitoring visits where appropriate.
**Experience Requirements**:
Required:
- Min. 4 years of direct site management (monitoring) experience in a bio/pharma/CRO.
**Educational Requirements**:
- B.A./B.Sc. with strong emphasis in science and/or biology.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
**Who we are**
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
**What we look for**
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue **Inventing For Life, Impacting Lives** while **Inspiring Your Career Growth.**
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
**Search Firm Representatives Please Read Carefully**
**Employee Status**:
Regular
**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R238007
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